Ambu AuraGain and Teleflex LMA Protector Fiberoptic Assessments in Elective Patients

Anesthesia Clinical Trial

Official title:

Randomized Comparison of Ambu AuraGain and Teleflex Protector Using Clinical and Fiberoptic Assessments in Elective Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02724956
• Other study ID #: 2017-0449
• Secondary ID: HSC-MS-14-0970
• Status: Completed
• Phase: N/A
• Start date: November 29, 2017
• Est. completion date: December 18, 2020

Study information

• Verified date: August 2021
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Participant is being asked to take part in this study because participant is going to have surgery that requires general anesthesia (in which participant is unconscious for the procedure).

During surgery, anesthesiologists often place a supraglottic airway device (SGAD). An SGAD is a device that helps participant breathe and may help the anesthesiologist put a breathing tube in participant's airway while participant is asleep during surgery. There are many different kinds of SGADs that are readily available for use by anesthesiologists during surgery. The SGADs that are being studied are the Ambu Auragain and the Teleflex LMA Protector.

The goal of this clinical research study is to compare the effectiveness of both devices.

This is an investigational study. Both of the SGADs that are being used on this study are FDA approved and are frequently used for the surgery that participant is going to have. It is investigational to compare the 2 devices.

Up to 50 participants will be enrolled in this study. All will take part at MD Anderson.

Description:

Surgery:

Participant will sign a separate consent form for surgery that describes the procedure and its risks. Participant will receive anesthesia through a catheter (sterile flexible tube) in one of participant's veins. During the procedure, participant's vital signs (heart rate, blood pressure, oxygen levels) will be monitored.

Study Groups:

If participant agrees to take part in this study, demographic information (such as participant's age, sex, and race) will be collected.

Participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. Participant will have an equal (50/50) chance of being assigned to either group. One group will use the Ambu Auragain, and the other will use the Teleflex LMA Protector.

Study Procedures:

After general anesthesia is given and participant falls asleep, the anesthesiologist will place the SGAD. The study staff will measure how easy it is to place the SGAD and how long each different step of the placement takes. Correct placement of the SGAD will be checked using a device with a small camera to help the doctor see participant's airway on a screen. A gastric tube will be placed to measure the volume of air and content of the stomach. Additionally the study doctor may place a breathing tube using the SGAD to make sure air is moving in and out of participant's lungs.

Participant will then be positioned and prepared for the surgery. The study staff will be collecting information from the time participant enters the operating room until the time participant leaves.

Additionally, participant will be interviewed after participant's surgery in the recovery room once participant is awake. Participant will be asked about any pain or soreness participant has, as well as any difficulty breathing, swallowing, or talking. This interview may take up to 5 minutes. Participation in the study will be over after the interview.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 18, 2020
• Est. primary completion date: December 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 years of age or older

2. Scheduled for an elective surgery requiring general anesthesia

3. Scheduled surgery < 4hrs

4. American Society of Anesthesiology (ASA) Physical Status I-III

5. Body Mass Index (BMI) < 30 kg/m2

6. Mallampati I-III

7. Able to bite upper lip via Upper Lip Bite Test (ULBT)

8. Inter-incisor distance > 2.5cm

9. Thyromental distance > 6cm

10. Full range of motion in the neck

11. Has provided written informed consent

Exclusion Criteria:

1. Under the age of 18 years old

2. ASA IV-V

3. Require prone positioning for surgery

4. Scheduled surgery > 4hrs

5. Liquid only diet < 2hrs and/or solids < 8hrs

6. High risk of regurgitation

7. Exhibits signs of respiratory tract pathology (including a sore throat preoperatively)

8. Mallampati IV

9. Unable to bite upper lip via Upper Lip Bite Test (ULBT)

10. Inter-incisor distance < 2.5cm

11. Thyromental distance < 6cm

12. Limited neck movement

13. Airway pathology/facial abnormality

14. Has been diagnosed with/exhibits any mental neurological disorder/disease/condition that would prevent participation in the study in the opinion of the investigator.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• Ambu AuraGain
Pre-curved, rigid airway tube, SGAD. Third generation Ambu laryngeal mask satisfying 3 fundamental airway management needs by integrating gastric access and intubation capability in an anatomically curved single-use device that facilitates rapid establishment of a safe airway. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
• Teleflex LMA Protector
Pre-curved, rigid airway tube, SGAD: A next-generation, single-use laryngeal mask with a dual gastric drainage channel and pharyngeal chamber. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
• Ambu aScope
Flexible scope which will be introduced into airway tube and guided through the SGAD until it will be possible to view the vocal cords. Description of the maximal optical view will be measured by the Percentage of Glottic Opening (POGO).

Locations

Country	Name	City	State
United States	UT MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Ambu A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1st Attempt Success With Supraglottic Airway Devices (SGAD)	Success defined as correct placement of SGAD. 1st Attempt success of SGAD either Ambu AuraGain or Teleflex LMA Protector during insertion and placement into an airway.	from Anesthesia Start to Anesthesia Stop, approximately 1 hour
Secondary	Oropharyngeal Leak Pressure (OLP)	OLP measured by a portable, handheld manometer.	from Anesthesia Start to Anesthesia Stop, approximately 1 hour
Secondary	Number of Participants With a Rate of Successful Intubation and Ventilation	Rate of successful intubation and ventilation by utilizing the SGAD as an intubation conduit guided by the Ambu® aScope™ 3 Slim.	from Anesthesia Start to Anesthesia Stop, approximately 1 hour
Secondary	Number of Participants With Ease of SGAD Insertion	Qualitative Assessment scale range of 1-4. (1) Easy; (2) Resistance, (3) Difficult; and (4) Unsuccessful.	from Anesthesia Start to Anesthesia Stop, approximately 1 hour
Secondary	Glottic Opening (POGO)	POGO Score of 100% on First Attempt at Device Placement. All participant assessments and observations (clinical data) completed and recorded during the 1st visit	from Anesthesia Start to Anesthesia Stop, approximately 1 hour
Secondary	Functionality of Gastric Tube Placement	Functionality of gastric drainage channel which will be inserted through the appropriate channel of the SGAD.	from Anesthesia Start to Anesthesia Stop, approximately 1 hour

External Links

•   The University of Texas (UT) MD Anderson Cancer Center Official Website